Actively Recruiting
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-05-18
194
Participants Needed
13
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
CONDITIONS
Official Title
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status of 0 or 1
- Histologically confirmed invasive HR+/HER2- breast cancer with tumor size larger than 1 cm (T1c-3; N0-3; M0)
- PD-L1 expression assessed using 22C3 antibody site with Combined Positive Score (CPS)
- Adequate organ function including neutrophil count > 1.5 x 10^9/L, platelet count > 75 x 10^9/L, hemoglobin > 90 g/L, lymphocyte count ≥ 1.5 x 10^9/L
- Blood biochemistry within specified limits: total bilirubin < 1.5 x ULN, ALT and AST < 1.5 x ULN, alkaline phosphatase < 2.5 x ULN, BUN and creatinine < 1.5 x ULN
- Left ventricular ejection fraction (LVEF) greater than 55%
- QT interval corrected by Fridericia (QTcF) less than 470 milliseconds on 12-lead ECG
- Pre-menopausal or non-sterilized women must use effective contraception during treatment and for 6 months after
- Willingness to provide informed consent and comply with study follow-up
You will not qualify if you...
- Stage IV breast cancer
- Inflammatory breast cancer
- Previous anti-tumor or radiation treatment for any malignant tumor except cured carcinoma in situ or certain skin cancers
- Concurrent anti-tumor treatments in other clinical trials
- Major surgery unrelated to breast cancer within 4 weeks before starting study treatment or incomplete recovery from such surgery
- Serious heart diseases including heart failure (LVEF less than 50%), uncontrolled arrhythmias, angina requiring medication, significant heart valve disease, transmural myocardial infarction, or poorly controlled hypertension
- Active infections requiring treatment or history of immunodeficiency including HIV or organ transplantation
- Chronic active hepatitis B or active hepatitis C (except stable or cured cases)
- Prior immunotherapy with immune-related adverse events affecting safety
- Known allergies to study medication components
- Pregnant or breastfeeding women, or women unwilling to use contraception during and 6 months after the study
- Serious concomitant diseases or conditions that may interfere with treatment or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Not Yet Recruiting
2
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, China
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Harbin, China
Not Yet Recruiting
5
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Not Yet Recruiting
6
Jinhua Municipal Central Hospital
Jinhua, China
Not Yet Recruiting
7
Nanchang People's Hospital
Nanchang, China
Not Yet Recruiting
8
Nantong First People's Hospital
Nantong, China
Not Yet Recruiting
9
Zhongshan Hospitall, Fudan University
Shanghai, China
Not Yet Recruiting
10
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, China
Not Yet Recruiting
11
Shaanxi Provincial Cancer Hospital
Xi'an, China
Not Yet Recruiting
12
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Not Yet Recruiting
13
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Not Yet Recruiting
Research Team
Z
Zhijun Dai, Professor
CONTACT
Y
Youyi Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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